This is a single center, open-label, non-randomized, Phase I dose finding study of the
investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in
patients with advanced solid tumors for whom curative therapy is not available. Please refer
to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the
combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a
member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been
clinically proven to be one of the most effective classes of anticancer therapies. Unlike
the currently marketed platinum-based drugs, satraplatin can be given orally.
- Histologically confirmed malignancy that is metastatic or unresectable and for which
standard curative or palliative chemotherapy measures do not exist or are no longer
- Life expectancy of at least 3 months
- Measurable or evaluable disease
- ECOG performance status of <= 2
- Willingness and ability to give informed consent
- Women who are pregnant or breastfeeding
- Other chemotherapy treatment less than 4 weeks prior to enrollment
- Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy